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This document summarizes the 510(k) premarket notification for the Quality Life Technologies Compressor Nebulizer, detailing its intended use, product specifications, and compliance with regulatory

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Determine if your device is a Class II device that requires a 510(k) submission.
2. Gather preclinical and clinical data that supports the safety and effectiveness of your device.
3. Identify a predicate device that is already legally marketed in the U.S. that is similar to your device.
4. Prepare a detailed comparison of the new device and the predicate device, highlighting similarities and any differences.
5. Draft the 510(k) Summary, including the device description, intended use, technological characteristics, and performance data.
6. Submit the 510(k) Summary along with the full 510(k) application to the FDA.

Who needs 510(k) Summary?

1. Manufacturers of Class II medical devices that wish to market their products in the U.S.
2. Companies looking to demonstrate that their device is substantially equivalent to a predicate device.

People Also Ask about

What are the three types of 510k?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

A 510(k) Summary is a document that a medical device manufacturer submits to the FDA to demonstrate that their device is substantially equivalent to a device that is already legally marketed.

Who is required to file 510(k) Summary?

Any medical device manufacturer who wishes to market a device that is not exempt from premarket notification is required to file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must include information about the device's intended use, technological characteristics, substantial equivalence to a predicate device, labeling information, and any performance testing data.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with the necessary information to determine whether the new device is substantially equivalent to an existing one, thereby ensuring safety and effectiveness.

What information must be reported on 510(k) Summary?

The information that must be reported includes the device's name, description, intended use, comparisons to predicate devices, performance testing data, labeling, and any potential risks associated with the device.